UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054987 |
|---|---|
| Receipt number | R000062826 |
| Scientific Title | The effect of motivational changes by transcutaneous auricular vagus nerve stimulation on motor performance |
| Date of disclosure of the study information | 2024/07/17 |
| Last modified on | 2026/01/17 21:40:01 |
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Basic information
Public title
The effect of motivational changes by transcutaneous auricular vagus nerve stimulation on motor performance
Acronym
Motivational changes by transcutaneous auricular vagus nerve stimulation and motor performance
Scientific Title
The effect of motivational changes by transcutaneous auricular vagus nerve stimulation on motor performance
Scientific Title:Acronym
Motivational changes by transcutaneous auricular vagus nerve stimulation and motor performance
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The present study is to examine the effects of motivational changes by taVNS on motor performance in healthy individuals.
Basic objectives2
Others
Basic objectives -Others
Basic science research for clinical application
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Endurance exercise test
Key secondary outcomes
Heart rate validly:HRV
VAS:level of subjective motivation and physical fatigue
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
taVNS(single session)
Interventions/Control_2
Sham taVNS(single session)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Agreement to participate in the study
Key exclusion criteria
1.Metal (cochlear implants, pacemakers, internal stimulators such as deep brain stimulation, medication pumps, etc.)
2.Medical history or family history of epilepsy
3.Medications for the central nervous system
4.History any side effects from electrical stimulation in the past
5.Medical history or current history of any psychiatric, cardiac, or orthopedic disorder
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Tomofumi |
| Middle name | |
| Last name | Yamaguchi |
Organization
Juntendo University
Division name
Department of Physical Therapy, Faculty of Health Science
Zip code
113-0033
Address
3-2-12 Hongo, Bunkyo-ku, Tokyo
TEL
03-3812-1780
t.yamaguchi.ja@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Tomofumi |
| Middle name | |
| Last name | Yamaguchi |
Organization
Juntendo University
Division name
Department of Physical Therapy, Faculty of Health Science
Zip code
113-0033
Address
3-2-12 Hongo, Bunkyo-ku, Tokyo
TEL
03-3812-1780
Homepage URL
t.yamaguchi.ja@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Juntendo University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional review board of Juntendo University
Address
3-2-12 Hongo, Bunkyo-ku, Tokyo
Tel
03-3812-1780
fhs8324015@juntendo.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
順天堂大学（東京都）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2024 | Year | 05 | Month | 28 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 24 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 07 | Month | 17 | Day |
Last modified on
| 2026 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062826
